CMC Operations, Director

THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

THE ROLE

Reporting to VP of CMC Ops, the Director of CMC Operations is responsible for drug substance development and manufacturing in support of clinical development and commercialization of 89bio's biologics pipeline drugs. The incumbent provides technical and organizational leadership, and work closely with cross-functional stakeholders to ensure drug substance development and manufacturing activities are executed seamlessly and in alignment with the integrated product development plan and program timeline

SPECIAL ADVISORY

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams

THE RESPONSIBILITIES

• Lead drug substance development and manufacturing operations from early to late development to maintain and advance company pipeline.
• Evaluate biologics-based processes for purity, cost, and yield optimization.
• Manage tech transfer, process familiarization, process development, GMP preparation and manufacturing activities of CDMOs.
• Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.
• Lead the efforts to assess/identify potential suppliers for drug substance development and manufacturing with adequate risk assessment.
• CDMO and other vendor identification, assessment, qualification, and management.
• Contract and Quality Agreement negotiation.
• Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.
• Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to ensure CMC and program goals are met.
• Author/review/approve the relevant CMC sections to enable global regulatory filings.
• Participate in developmental stage-appropriate analytical activities.
• Develop and maintain adequate in-process analytical testing and controls in conjunction with CDMO and internal Analytical Development, Quality Control, and Regulatory.
• Contribute to Reference Standard and Stability Programs
• Contribute to Comparability Assessments
• Serve as Person-in-Plant for CDMO scale-up manufacturing runs
• On-board and familiarize new Tech-Ops members on Process Development and Manufacturing activities for Drug Substance and Critical Enzyme Reagents

 THE QUALIFICATIONS

• Preferably a Ph.D. (minimum MSc degree) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.
• 8+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase drug substance manufacturing.
• Working knowledge of drug substance and drug product analytical methods.
• Demonstrated strong project and cross-functional team leadership.
• Thorough understanding and working experience in drug substance development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
• Extensive working experience with management and oversight of the manufacturing activities at CDMOs.
• Excellent written and verbal communication, project planning, presentation skills and interpersonal skills.
• Highly collaborative, and ability to cultivate strong internal/external network of relationships.
• The ability to anticipate and remediate problems that arise is essential.
• Strong analytical problem-solving & interpersonal skills.
• Experience with working in high growth, collaborative organizations.
• Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a high growth, entrepreneurial environment.
• Highly adaptable and responsive to technical and business opportunities and needs - Comfortable delivering against challenging commitments.

 SALARY & LEVEL

89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $205,000 - $225,000 and will be commensurate with experience.

THE PERKS

• Competitive health insurance coverage
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• Women's forum / mentoring
• Office based in the heart of San Francisco, near plenty of shops and restaurants
• Fun opportunities to engage with co-workers in-person and remotely

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.  Proof of Covid vaccination is a condition of employment. 

Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.